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Randomized Controlled Trial (Open-label)
The Lancet

Type 2 Diabetes Remission Through Calorie Restriction: The Landmark DiRECT Trial

The DiRECT trial demonstrated that intensive weight management through calorie restriction can achieve remission of type 2 diabetes in nearly half of participants, challenging the conventional view of diabetes as a progressive, irreversible condition.

March 15, 2018

Core Finding

After 12 months, 46% of participants in the intervention group achieved remission of type 2 diabetes (HbA1c <6.5% without medication) compared to just 4% in the control group. Remission was strongly associated with weight loss—64% of those who lost ≥15 kg achieved remission.

Research Background

Type 2 diabetes has traditionally been viewed as a progressive, irreversible condition requiring escalating medication. However, the twin cycle hypothesis proposed that ectopic fat accumulation in the liver and pancreas drives insulin resistance and beta-cell dysfunction. The DiRECT (Diabetes Remission Clinical Trial) study was designed to test whether substantial weight loss could reverse this process.

Study at a Glance

Study Overview

Source: The Lancet (2018)

Duration: 12-month primary endpoint (extended to 24 months)

Intervention: Very low calorie diet (825-853 kcal/day) for 3-5 months, then structured food reintroduction

Control: Best practice guidelines per NICE

  • Phase 1 (3-5 months): Total diet replacement using formula low-energy diet (825-853 kcal/day)
  • Phase 2 (2-8 weeks): Structured food reintroduction with weekly support
  • Phase 3 (long-term): Monthly visits for weight loss maintenance support
  • Medication management: All glucose-lowering medications discontinued at baseline (except metformin if eGFR permitted)
  • Support framework: Regular nurse/dietitian visits using a cognitive behavioral approach

Clinical Implications

  1. Paradigm shift: Type 2 diabetes remission should be a primary treatment goal, not just management
  2. Early intervention: Patients with shorter diabetes duration (<6 years) had higher remission rates
  3. Structured support: The Counterweight program provided a reproducible framework for primary care
  4. Economic impact: Remission could reduce lifetime medication costs and diabetes complications

Important Caveats

  • Participants had T2D for <6 years; longer duration may reduce remission potential
  • The intervention required intensive support from trained practitioners
  • Weight regain at 24 months led to loss of remission in some participants—maintenance is crucial
  • Not all patients achieved ≥15 kg weight loss; individual response varied

Mechanisms of Remission

The study supports the twin cycle hypothesis:

  1. Calorie deficit rapidly depletes liver fat (within days)
  2. Improved hepatic insulin sensitivity normalizes fasting glucose
  3. Gradual loss of pancreatic fat restores first-phase insulin secretion
  4. Beta-cell function recovers when intrapancreatic triglyceride content normalizes

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Type 2 Diabetes Remission Through Calorie Restriction: The Landmark DiRECT Trial | Paper Interpretation